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Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Primary Purpose

Malignant Pleural Effusion, Malignant Ascites

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring Malignant Pleural Effusion, Malignant Ascites, Tocilizumab, IL-6 receptor antagonist, peritoneal cavity, pleural cavity, intraperitoneal, intrapleural

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter ECOG performance status: 0-2 Able to read and sign consent form in English and provide informed consent Exclusion Criteria: Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 1.5 times the upper limit of normal ALT/SGPT > 1.5 times the upper limit of normal Total bilirubin > 1.5 times the upper limit of normal Creatinine > 1.5 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3 Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits Pregnant women Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be >30 days prior to the first treatment visit Investigational drug use within 30 days prior to first treatment dose History of systemic autoimmune disease Patient with known hypersensitivity to tocilizumab Active infection Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine -

Sites / Locations

  • Allegheny Health Network Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm - intracavitary tocilizumab

Arm Description

Four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.

Outcomes

Primary Outcome Measures

Successful intra-cavitary administration of tocilizumab
Number of patients with successful administration of tocilizumab
Adverse Events
To identify the frequency and type of adverse events (AE) following intrapleural or intraperitoneal administration of tocilizumab at doses up to 2.5 mg (intrapleural) or 25 mg (intraperitoneal) using CTCAE v5.0

Secondary Outcome Measures

Pharmacokinetics Analysis
Measuring serum receptor occupancy levels
Pharmacokinetics Analysis
Measuring intracavity fluid receptor occupancy levels
Biomarkers
Change in Pleural cytokine concentrations
Biomarkers
Change in Peritoneal Cytokine concentrations
Biomarkers
Change in immune cell density

Full Information

First Posted
July 28, 2023
Last Updated
August 30, 2023
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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1. Study Identification

Unique Protocol Identification Number
NCT06016179
Brief Title
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
Official Title
Phase I Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.
Detailed Description
This is an open label, Phase 1, intra-patient dose escalation study to determine the feasibility of catheter-based intra-pleural and intra-peritoneal administration of tocilizumab at doses up to 50μg/mL in patients with malignant pleural effusions (MPE) and malignant ascites (MA) and to determine the frequency and type of adverse events. Tocilizumab is a monoclonal antibody inhibitor of the IL-6 receptor, FDA-approved for intravenous administration in autoimmune disorders and cytokine release syndrome. The current study aims to adapt this agent for intra-cavitary administration in patients A drain catheter will be placed in the patient as standard of care treatment. Following the procedure, on that day and once a week for the following 3 weeks, tocilizumab will be administered to the patient via the drain. Each treatment session will last about one hour, and participants donate 6 milliliters (1 teaspoon) of blood before and after the treatment. Fluid drained from the body cavity, which is normally discarded, will instead be collected for analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Malignant Ascites
Keywords
Malignant Pleural Effusion, Malignant Ascites, Tocilizumab, IL-6 receptor antagonist, peritoneal cavity, pleural cavity, intraperitoneal, intrapleural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Intra-patient dose escalation administration of tocilizumab via pleural and peritoneal catheters
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm - intracavitary tocilizumab
Arm Type
Experimental
Arm Description
Four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra
Intervention Description
Each patient will receive four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.
Primary Outcome Measure Information:
Title
Successful intra-cavitary administration of tocilizumab
Description
Number of patients with successful administration of tocilizumab
Time Frame
6 weeks
Title
Adverse Events
Description
To identify the frequency and type of adverse events (AE) following intrapleural or intraperitoneal administration of tocilizumab at doses up to 2.5 mg (intrapleural) or 25 mg (intraperitoneal) using CTCAE v5.0
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics Analysis
Description
Measuring serum receptor occupancy levels
Time Frame
4 weeks
Title
Pharmacokinetics Analysis
Description
Measuring intracavity fluid receptor occupancy levels
Time Frame
4 weeks
Title
Biomarkers
Description
Change in Pleural cytokine concentrations
Time Frame
4 weeks
Title
Biomarkers
Description
Change in Peritoneal Cytokine concentrations
Time Frame
4 weeks
Title
Biomarkers
Description
Change in immune cell density
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter ECOG performance status: 0-2 Able to read and sign consent form in English and provide informed consent Exclusion Criteria: Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 1.5 times the upper limit of normal ALT/SGPT > 1.5 times the upper limit of normal Total bilirubin > 1.5 times the upper limit of normal Creatinine > 1.5 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3 Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits Pregnant women Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be >30 days prior to the first treatment visit Investigational drug use within 30 days prior to first treatment dose History of systemic autoimmune disease Patient with known hypersensitivity to tocilizumab Active infection Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Wagner, MD
Phone
412-359-3731
Email
patrick.wagner@ahn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Dennis, RN, BS
Phone
412-330-6152
Email
laurie.dennis@ahn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Wagner, MD
Organizational Affiliation
Director of Complex General Surgical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny Health Network Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

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